1. Field of the Invention
This invention relates to laparoscopic implants designed to be implanted in the body of a patient around a biological organ having a pouch or duct to regulate functioning of the organ or duct. More specifically, the present invention is directed to an implantable telemetrically-powered and controlled ring having a detachable antenna suitable for use as a gastric band to treat obesity or as an artificial sphincter.
2. Description of the Related Art
Obesity refers to a body weight that exceeds the body's skeletal and physical standards. One well recognized parameter used to measure obesity is Body Mass Index (BMI) because it takes into account patient height and not just weight. BMI is calculated by dividing weight by height squared and is expressed in kg/m2.
Obesity is usually defined as a BMI of 30 kg/m2 or greater, and is further broken down into Class I (BMI of 30-34.9 kg/m2), Class II (BMI of 35-39.9 kg/m2) also called severe obesity, and Class III (BMI of 40 kg/m2 or greater), also called extreme obesity. Obesity is considered “morbid” when the BMI is over 40 (extreme obesity) or the BMI is over 35 (severe obesity) and serious comorbidities are present.
Obesity is well recognized as a serious health problem, and is associated with numerous health complications, ranging from non-fatal conditions to life-threatening chronic diseases. Surgical intervention generally is the treatment of choice for patients afflicted with morbid obesity. Such intervention not only mitigates the myriad health problems arising from overweight, but may also reduce the risk of early death of the patient. Left untreated, morbid obesity may reduce a patient's life expectancy by ten to fifteen years.
Morbidly obese patients as a group are poorly adapted to attain sustainable long-term weight loss using non-surgical approaches, such as strict diets combined with exercise and behavioral modification, even though such methods are acknowledged to be the safest. For this reason, there is a continuing need for direct intervention to provide effective, long-term treatments for morbid obesity. Three main surgical procedures are currently in use: Roux-en-Y Gastric Bypass (“RYGB”), Vertical Banded Gastroplasty (“VBG”) and Adjustable Gastric Banding (“AGB”).
In RYGB a small stomach pouch is created and a Y-shaped section of the small intestine is attached to the pouch so that food bypasses the lower stomach, the duodenum and the first portion of the jejunum. The RYGB procedure is both restrictive, in that the small pouch limits food intake and malabsorptive, in that the bypass reduces the amount of calories and nutrients the body absorbs.
VBG employs a non-adjustable synthetic band and staples to create a small stomach pouch. AGB employs a constricting synthetic ring that is placed around the upper end of the stomach to create an artificial stoma within the stomach. The band is filled with saline solution and is connected to small reservoir/access-port located under the skin of the abdomen. The AGB band may be inflated, thereby reducing the size of the stoma, or deflated, thus enlarging the stoma, by puncturing the access-port with a needle and adding or removing saline solution. Both VBG and AGB are purely restrictive procedures, and have no malabsorptive effect.
An example of the AGB technique is described, for example, in U.S. Pat. No. 5,074,868 to Kuzmak. As described in the '868 patent, a flexible band of elastomeric material is implanted around the stomach to form a closed loop defining a fixed pre-established diameter. The body of the flexible band includes an expandable chamber, which is linked via a tube to a subcutaneous injection port. Fluid may be introduced into the injection port using a syringe to add or remove fluid from the expandable chamber and thus vary the internal diameter of the band and the diameter of the stoma. In this way, expansion of the chamber, in combination with the pre-established and fixed diameter of the band, permits adjustment of the stoma diameter and thus regulation of the quantity of food ingested.
The injection port is the source of many of the problems encountered with the hydraulic gastric bands, including infection, damage to the tube due to imprecise puncturing with the needle, discomfort to the patient created by the port and difficulty in locating the port (often necessitating the use of x-ray to determine the location and orientation of the port).
In addition, although the injection port makes it possible to make limited adjustments to the diameter of the ring without major surgical intervention, installation of the band may be accompanied by intolerance phenomena, such as vomiting. This drawback may arise from various causes, including too great a reduction in the diameter of the stoma, ineffective action of the band due to too great a stoma diameter, obstruction, infection or local or general inflammation.
Accordingly, it sometimes is necessary to re-operate, either to relieve the patient or to adjust or change the previously-implanted band. In such cases, the previously-implanted band must be cut and either removed or replaced, during operations that are difficult to carry out, difficult for the patient to tolerate and costly.
U.S. Pat. No. 5,938,669 to Klaiber et al. addresses some of the issues arising from use of an injection port, and describes a gastric band that is adjusted using a remote control in a non-invasive manner. The device includes a control box that is implanted in the body of the patient and coupled to the gastric band. The control box includes a battery-operated electric pump and valve that are coupled between an expandable chamber and a fluid reservoir. The control box also contains a radiofrequency transceiver and microprocessor, which are arranged to communicate with an external remote control to control operation of the pump to add or remove fluid from the reservoir to the expandable chamber, thereby selectively varying the diameter of the stoma opening. The external remote control is operated by a physician.
All of the foregoing surgical techniques involve major surgery and may give rise to severe complications. Recent developments have focused on the use of laparoscopic implantation of the gastric ring to minimize patient discomfort and recuperation time.
In view of the foregoing, it would be desirable to provide apparatus and methods for regulating functioning of a body organ or duct that provides high precision in a degree of constriction imposed upon the organ or duct, without the drawbacks associated with the use of previously-known injection ports.